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President Trump’s touting of Regeneron Pharmaceuticals’ COVID-19 antibody treatment as a cure for the disease that would imminently become available to all Americans for free has come under congressional scrutiny. Read More
HHS on Wednesday shot down a story claiming that department officials had asked the FDA to consider COVID-19 Emergency Use Authorizations (EUAs) as “pre-licensures” even as the FDA issued a statement detailing why pre-licensure approvals would not be appropriate for COVID-19 vaccines. Read More
Cytiva has finalized a $31 million deal with HHS’ Biomedical Advanced Research and Development Authority to develop and manufacture COVID-19 vaccine component parts. Read More
San Diego-based Allele Biotechnology has filed lawsuits against Regeneron Pharmaceuticals, Pfizer and BioNTech, alleging infringement of its patent for mNeonGreen, a reagent used to develop COVID-19 therapies. Read More
The Institute for Clinical and Economic Review (ICER) has launched a cloud-based, cost-effectiveness modeling program for use by health technology assessment (HTA) agencies when projecting COVID-19 treatment costs. Read More
Two FDA expert panels voted in favor of FDA approval for Alkermes’s new drug application (NDA) for its schizophrenia and bipolar disorder investigational drug OLZ/SAM (olanzapine/samidorphan) in a joint session on Friday. Read More